ISPE Guides

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  1. MOST RECENT

    ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2024.

    Languages: English

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  2. MOST RECENT

    ISPE Guide: ATMPs – Validation Methods & Controls▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2025.

    Languages: English

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  3. MOST RECENT

    Guide: Sustainability▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2025.

    Languages: English

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  4. MOST RECENT

    ISPE Guide: ATMPs - Recombinant AAV Comparability and Lifecycle Management▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2024.

    Languages: English

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  5. MOST RECENT

    ISPE Guide: ATMPs - Allogeneic Cell Therapy▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2024.

    Languages: English

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  6. MOST RECENT

    ISPE Guide: Biopharmaceutical Process Development and Manufacturing▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/31/2013.

    Languages: English

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  7. MOST RECENT

    ISPE Guide: ATMPs - Autologous Cell Therapy▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2021.

    Languages: English

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  8. MOST RECENT

    APQ Guide: Change Management (CM) System▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2022.

    Languages: English

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  9. MOST RECENT

    ISPE Guide: 503B Compounding▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2023.

    Languages: English

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  10. MOST RECENT

    APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/22/2022.

    Languages: English

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